No Aspirin Post-STEMI Stent; Sapien 3 Stroke Risk; and More

Studies served up a slew of data at the virtual TCT Connect conference on ditching aspirin sooner after ST-segment myocardial infarction (STEMI); stroke risk with different transcatheter aortic valves; real-world results with a mechanical thrombectomy device for pulmonary embolism (PE); and mitral valve repair in cardiogenic shock.

TICO-STEMI

Cutting aspirin from a ticagrelor (Brilinta)-based dual antiplatelet therapy (DAPT) regimen 3 months after a drug-eluting stent for STEMI got further support from the TICO trial STEMI substudy at 1 year follow-up.

Net adverse clinical events — pooling together TIMI major bleeding, all-cause death, MI, stent thrombosis, stroke, or target-vessel revascularization — were a relative 27% less common with ticagrelor monotherapy after 3-month DAPT versus 12 months of DAPT (3.7% vs 5.0% at 12 months, P=0.27).

TIMI major bleeding over 12 months was 68% less common with the shorter DAPT regimen (0.9% vs 2.9%, P=0.02), reported Byeong-Keuk Kim, MD, PhD, of Yonsei University Severance Cardiovascular Hospital College of Medicine in Seoul.

Major adverse cardiac and cerebrovascular events at the same point were similar between groups (2.7% vs 2.5%, respectively, P=0.81). No significant interaction was seen with clinical presentation in terms of complex PCI or bleeding risk score, although risk numerically was highest in the complex cases and lowest in the high bleeding risk patients.

“Care should be taken in applying these results to the overall STEMI population, especially those at high risk for ischemia,” Kim said.

A similar strategy was safe and reduced bleeding in the large randomized TWILIGHT trial, but that trial had specifically excluded STEMI patients and waited until 3 months of DAPT to randomize patients without early events.

Waiting until 3 months to decide on DAPT duration is important, argued TCT press conference discussion panelist Marco Valgimigli, MD, PhD, of Cardiocentro Ticino in Lugano, Switzerland.

His GLOBAL LEADERS trial supporting safety of ticagrelor monotherapy had 13% of its population with STEMI — twice as many as in TICO — and likewise suggested no interaction with STEMI.

These studies have been “very consistent in showing the safety of dropping aspirin at 3 months in patients who are treated with ticagrelor after a STEMI or acute coronary syndromes or high-risk PCI,” commented press conference panelist Gregg Stone, MD, of Icahn School of Medicine at Mount Sinai in New York City. “We know that aspirin is not a major drug to prevent stent thrombosis. Most stent thromboses occur within the first 30 days anyway. And when you’ve got a potent P2Y12 inhibitor on board, such as ticagrelor, it does not seem like the aspirin adds much and clearly it causes more major bleeding.”

That’s not necessarily the case for clopidogrel (Plavix), cautioned TCT press conference moderator Ajay Kirtane, MD, of NewYork-Presbyterian/Columbia University Medical Center in New York City. “Typically you’re going to need an agent with less variability.”

SOLVE-TAVI

In 1-year results from the SOLVE-TAVI two-by-two factorial design trial, the biggest surprise was a higher stroke risk with the Sapien 3 devices versus Evolut R for transcatheter aortic valve replacement (TAVR).

As with previously reported 30-day results, the composite primary endpoint of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation came out similar between the two device types at 1 year (40.4% Sapien 3 vs 41.9% Evolut R, P=0.76).

Stroke at 1 year, though, was more than seven-fold elevated with Sapien 3, with a rate of 6.9% versus 1.0% with Evolut R (P=0.002), Hans-Josef Feistritzer, MD, PhD, of the Heart Center Leipzig at University Hospital in Leipzig, Germany, reported. Landmark analysis suggested the difference was driven by stroke before 30 days.

Sapien’s stroke rate was higher than the 3% to 5% seen in prior intermediate-risk cohort trial data, which hadn’t suggested a big difference between TAVR platforms, although not head-to-head trials, cautioned TCT study discussant Megan Coylewright, MD, MPH, of Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire.

Baseline characteristics and risk factors were similar between valve groups, Feistritzer noted. One possible explanation is that “our center has very high experience with the CoreValve system,” he said, but further analyses looking for potential confounders like carotid stenosis are planned. Cerebral protection device use was not systematically assessed.

The 447-patient trial was “vastly underpowered to detect small differences in stroke, let alone large differences,” commented Stone at the session. “Other studies have shown the opposite finding as relating to strokes and DWI defects and neither of those were definitive either. So I think I can say pretty confidently that there’s not a seven-fold difference in stroke rates between these two devices. I’m willing to take that one to the bank.”

Randomization to general anesthesia versus conscious sedation came out similar on all endpoints.

FLASH

Interim real-world registry results with the FlowTriever mechanical thrombectomy device showed “excellent” safety for PE without routine need for thrombolytics, reported Catalin Toma, MD, of the University of Pittsburgh Medical Center.

There were no deaths within 48 hours of the procedure, no damage to lungs or heart, and only one access site complication despite the large bore access among 230 U.S. patients at elevated risk (93% submassive and 7% massive PE, 38% with contraindication to lytics).

The major adverse event rate at 48 hours was 1.3%, compared with about 10% major bleeding incidence in prior large studies of advanced treatment options reliant on thrombolytics. These three events in the registry were:

• A clinically-significant hematoma in a patient who needed adjunctive thrombolysis with tissue plasminogen activator
• A case of significant hemoglobin drop
• An access-related bleeding event that was related to a different vascular procedure

On-table hemodynamic improvement averaged a 7.0 mm Hg drop in pulmonary artery pressure (21.9%, P<0.0001 vs baseline) and a 22.7 bmp decrease in heart rate. Dyspnea scores also improved significantly at 48 hours.

“Many of these patients with so-called submassive PE would be categorized as having cardiogenic shock by their hemodynamic indices,” commented TCT session co-chair Sahil Parikh, MD, of NewYork-Presbyterian/Columbia University Medical Center in New York City. “Here you show that there’s a cardiac index of 1.7 that rose to 1.9 after treatment. But I was disappointed not more people had complete ascertainment of hemodynamics. Don’t you think these are the kind of data we need to really quantitatively move this field to the next level?”

Before-after acute hemodynamic comparisons were available for 223 of the 230 patients. Cardiac index was reported for only the 43 patients with low baseline cardiac index (less than 2.0 l/min/m²). For patients with normal cardiac index at baseline, there was no significant change, Toma noted.

“But I absolutely agree that you would be surprised how bad these hemodynamics are in patients who are seemingly stable or currently stable at baseline,” he added.

“Further data will help design definitive studies in PE,” Toma concluded.

“I think that’s the future,” commented session co-moderator Frank Veith, MD, of NYU Langone Health in New York City.

IREMMI

Percutaneous mitral valve repair with the MitraClip appeared safe in MI patients regardless of cardiogenic shock, the IREMMI international registry showed.

Among 93 consecutive patients with acute mitral regurgitation following MI treated with the device in Europe, North America, and Israel, 50 were in cardiogenic shock.

Technical and procedural success, major complications, and outcomes were similar between those with and without shock. Shock didn’t independently predict mortality and heart failure readmission at a median 7 months of follow-up.

“Cardiogenic shock, when adequately supported, does not seem to influence short and mid-term outcomes,” concluded Rodrigo Estévez-Loureiro, MD, PhD, of University Hospital Alvaro Cunqueiro in Vigo, Spain, in the presentation. “The development of cardiogenic shock should not preclude percutaneous mitral valve repair in this scenario.”